Applied Clinical Trials
A compilation of recent notable news developments that pertain to the clinical trials industry.
Novartis and a consortium of life sciences companies announced a collaboration to accelerate the development, manufacture, and delivery of vaccines, diagnostics, and treatments for COVID-19 in response to the pandemic. They have joined forces with the Bill & Melinda Gates Foundation.
As a first step, the 15 companies have agreed to share their proprietary libraries of molecular compounds that already have some degree of safety and activity data-with the COVID-19 Therapeutics Accelerator launched by the Gates Foundation, Wellcome, and Mastercard two weeks ago. Accelerator will quickly screen the compounds for potential against COVID-19. Successful hits would move rapidly into in vivo trials in as little as two months.
Accelerated Enrollment Solutions (AES), a business of PPD, Inc., and Science 37 are collaborating to recruit and enroll clinical trial participants who live beyond the geographic location of traditional research sites. The companies also are working to rapidly deliver continuity solutions for clinical trials affected by the COVID-19 pandemic, including the use of telehealth to remotely screen patients and conduct study visits.
The collaboration enables AES to provide increased patient access by reaching beyond its existing, physical site infrastructure of more than 180 research sites. These patients can instead participate in AES studies through Science 37’s Metasite, a hybrid clinical trial methodology that combines traditional site visits with remote trial capabilities, allowing patients located virtually anywhere to participate in a clinical trial.
Asklepios BioPharmaceutical, Inc. (AskBio), a a clinical-stage adeno-associated virus (AAV) gene therapy company, has entered into a research collaboration and licensing agreement with the University of North Carolina at Chapel Hill (UNC) for the development and commercialization of gene therapy for Angelman syndrome..
Angelman syndrome is a rare neurogenetic disorder caused by the loss of function of the UBE3A gene. The disorder occurs in approximately one in 15,000 people, or about 500,000 individuals worldwide, and there is currently no cure. In addition to life-altering symptoms such as speech and motor deficits, more than 80% of Angelman syndrome patients experience epilepsy.
Zymewire, a SaaS company, has launched CovidCollaborators.org, an online directory of expert, pro-bono, and discounted clinical development services being offered in the fight against COVID-19. Some of the services being offered include clinical research, clinical software, EDC, manufacturing, investigator training, patient recruitment, use of facilities, virtual services, and clinical trial management.
Pivotal, a privately held European CRO, has acquired Akcelis BVBA, a full-service provider of patient enrollment and retention solutions for clinical trials in the life sciences industry. Akcelis was founded in 2015 in Belgium.
- Staff and wire reports